Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion
Primary Purpose
Metastatic Cancer
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
ibuprofen
morphine sulfate
management of therapy complications
pleurodesis
Sponsored by
About this trial
This is an interventional supportive care trial for Metastatic Cancer focused on measuring malignant pleural effusion
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the following:
- Histologically proven pleural malignancy
- Typical features of pleural malignancy seen on direct vision during thoracoscopy
- Pleural effusion in the context of histologically proven cancer elsewhere
- No primary lymphoma or small cell lung carcinoma
- All patients undergoing thoracoscopy for suspected malignant pleural effusion are eligible
PATIENT CHARACTERISTICS:
- Life expectancy > 1 month
- Not pregnant or nursing
- No history of GI bleeding or untreated peptic ulceration
- No known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, or paracetamol
- No hypercapnic respiratory failure
- No known intravenous drug abuse
- No severe renal or liver disease
- No known bleeding diathesis
- Able to give informed consent
PRIOR CONCURRENT THERAPY:
- More than 2 weeks since prior and no concurrent corticosteroid therapy
- No concurrent warfarin therapy
No other concurrent analgesics
- Analgesics used as a breakthrough regimen are allowed from trial entry to tube withdrawal at day 3 post-pleurodesis (i.e., regular paracetamol, assigned study analgesia, and breakthrough medication only, including opiate slow release patches)
No concurrent enrollment on another clinical study
- Patients may participate in other trials immediately after completion of current trial, excluding those involving further pleural procedures or analgesia trials in which patients must wait at least 3 months after completion of current trial
Sites / Locations
- Oxford Radcliffe HospitalRecruiting
Outcomes
Primary Outcome Measures
Average pain score over 72 hours post pleurodesis (total pain relief score) by a Visual Analogue Scale of pain relief and pain intensity every 6 hours
Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion, censored for survival)
Secondary Outcome Measures
Presence of chronic chest pain on the side of the pleurodesis at 6 weeks and 3 months post randomization
Change in hemoglobin and white cell count from day 0 to day 3
Change in renal function and liver function (i.e., ALT or AST, bilirubin, albumin, and alk phos) from day 0 to day 3
Change in Inflammatory markers from day 0 and day 3 (e.g., CRP, WCC) from day 0 to day 3
Change in alveolar PO2-arterial PO2 (A-a) gradient (on air) on day 0 and day 3
Continuous oximetry monitoring from day 0 to day 3 (on air unless saturation < 90%)
Average conscious level measured by Glasgow Coma scale from day 0 to day 3
Drug- and talc-related adverse reactions
Complications from chest drain insertion
Presence of chronic chest wall pain assessed at all follow-up visits
Full Information
NCT ID
NCT00644319
First Posted
March 25, 2008
Last Updated
July 7, 2009
Sponsor
Oxford University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00644319
Brief Title
Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion
Official Title
A 2 x 2 Factorial Trial to Assess Whether Non-Steroidal Anti-Inflammatory Analgesics and Small Bore Chest Tubes Are Less Painful Than Opiate Analgesics and a Large Bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion [TIME1]
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Oxford University Hospitals NHS Trust
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Morphine and ibuprofen help lessen pain caused by pleurodesis. It is not yet known whether one drug is more effective than the other in lessening pleurodesis-related pain or whether the size of the chest drain tube affects pain.
PURPOSE: This randomized clinical trial is studying ibuprofen to see how well it works compared with morphine in treating pain in patients undergoing pleurodesis for malignant pleural effusion.
Detailed Description
OBJECTIVES:
Primary
To evaluate the efficacy of a non-steroidal based regimen comprising ibuprofen in decreasing post-pleurodesis pain as compared to an opiate-based regimen comprising morphine sulfate in patients with malignant pleural effusion.
To evaluate whether chest drain size influences the amount of post-pleurodesis pain.
OUTLINE: This is a multicenter study. Patients are stratified according to histological tissue type (mesothelioma vs non-mesothelioma) and thoracoscopic procedure. Patients are randomized to 1 of 4 treatment arms.
Arm I: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3.
Arm II: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3.
Arm III: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3.
Arm IV: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3.
All patients will receive regular background analgesia comprising paracetamol 4 times daily on days 0-3. Patients not adequately treated with these regimens may also receive rescue analgesia comprising morphine sulfate IV on days 0-3.
After completion of study treatment, patients are followed at 1, 3, and 6 months, and periodically thereafter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
malignant pleural effusion
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ibuprofen
Intervention Type
Drug
Intervention Name(s)
morphine sulfate
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Intervention Type
Procedure
Intervention Name(s)
pleurodesis
Primary Outcome Measure Information:
Title
Average pain score over 72 hours post pleurodesis (total pain relief score) by a Visual Analogue Scale of pain relief and pain intensity every 6 hours
Title
Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion, censored for survival)
Secondary Outcome Measure Information:
Title
Presence of chronic chest pain on the side of the pleurodesis at 6 weeks and 3 months post randomization
Title
Change in hemoglobin and white cell count from day 0 to day 3
Title
Change in renal function and liver function (i.e., ALT or AST, bilirubin, albumin, and alk phos) from day 0 to day 3
Title
Change in Inflammatory markers from day 0 and day 3 (e.g., CRP, WCC) from day 0 to day 3
Title
Change in alveolar PO2-arterial PO2 (A-a) gradient (on air) on day 0 and day 3
Title
Continuous oximetry monitoring from day 0 to day 3 (on air unless saturation < 90%)
Title
Average conscious level measured by Glasgow Coma scale from day 0 to day 3
Title
Drug- and talc-related adverse reactions
Title
Complications from chest drain insertion
Title
Presence of chronic chest wall pain assessed at all follow-up visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the following:
Histologically proven pleural malignancy
Typical features of pleural malignancy seen on direct vision during thoracoscopy
Pleural effusion in the context of histologically proven cancer elsewhere
No primary lymphoma or small cell lung carcinoma
All patients undergoing thoracoscopy for suspected malignant pleural effusion are eligible
PATIENT CHARACTERISTICS:
Life expectancy > 1 month
Not pregnant or nursing
No history of GI bleeding or untreated peptic ulceration
No known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, or paracetamol
No hypercapnic respiratory failure
No known intravenous drug abuse
No severe renal or liver disease
No known bleeding diathesis
Able to give informed consent
PRIOR CONCURRENT THERAPY:
More than 2 weeks since prior and no concurrent corticosteroid therapy
No concurrent warfarin therapy
No other concurrent analgesics
Analgesics used as a breakthrough regimen are allowed from trial entry to tube withdrawal at day 3 post-pleurodesis (i.e., regular paracetamol, assigned study analgesia, and breakthrough medication only, including opiate slow release patches)
No concurrent enrollment on another clinical study
Patients may participate in other trials immediately after completion of current trial, excluding those involving further pleural procedures or analgesia trials in which patients must wait at least 3 months after completion of current trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Davies, MD
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1865-225-205
Email
robert.davies@ndm.ox.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion
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